DLR :envihab consists of eight separate modules to conduct cardiovascular, bone and muscle research and has laboratories for studying the effects of Oxygen reduction and pressure decrease on test subjects. To operate the labs, it was required to establish a hazard assessment to show compliance to safety requirements. The approach chosen to derive safety requirements applicable for this special use is explained. Main hazards are caused by the ventilation system which can be set to support different air mixtures (e. g. increase Nitrogen and reduce Oxygen). To meet safety requirements, a mix of devices was used. As some of the devices were built for use in different industries, a comparison of different safety standards (IEC 61508 and IEC 60601) was established. The assessment is based on a functional analysis and considers external interfaces as well as system states and modes. Fault trees were established to show compliance to safety requirements.
Fachvortrag: MEDCONF Nord, Hamburg, 13. Juni 2017